Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the principle of capillary electrophoresis and standard analytical performance metrics. There is no mention of AI or ML.

Therapeutic

No
The device is an in vitro diagnostic (IVD) device used for the measurement of HbA1c, which aids in the diagnosis and monitoring of diabetes. It does not directly treat or prevent a disease.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the CAPI 3 Hb A1c kit is "used as an aid in diagnosis of diabetes" and "for the monitoring of long-term blood glucose control in individuals with diabetes mellitus." These uses directly relate to diagnosing and managing a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical instrument (CAPILLARYS 3 TERA instrument) that uses capillary electrophoresis, injects samples, performs separation, and detects hemoglobins. This involves significant hardware components and processes, not just software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The CAPI 3 Hb A1c kit is intended for in vitro Diagnostic Use Only."
Purpose: The device is designed to analyze human blood samples in vitro (outside the body) to measure HbA1c levels. This measurement is used as an aid in the diagnosis and monitoring of diabetes, which are clinical purposes.
Device Description: The description details a laboratory-based process involving sample preparation, capillary electrophoresis, and detection, all of which are characteristic of in vitro diagnostic procedures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The CAPI 3 Hb A1c kit is intended for separation and quantification of the HbA1c glycated fraction of hemoglobin (in IFCC unit (mmol/mol) and NGSP unit (%)) in venous whole human blood, by capillary electrophoresis in alkaline buffer with the CAPILLARYS 3 TERA instrument of hemoglobin A1c is used as an aid in diagnosis of diabetes, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus. The CAPI 3 Hb A1c kit is intended for in vitro Diagnostic Use Only.

Product codes (comma separated list FDA assigned to the subject device)

PDJ

Device Description

The CAPILLARYS 3 TERA instrument uses the principle of capillary electrophoresis in free solution. With this technique, charged molecules are separated by their electrophoretic mobility in an alkaline buffer with a specific pH. Separation occurs according to the electrolyte pH and electroosmotic flow.

The CAPILLARYS 3 TERA instrument has silica capillaries functioning in parallel allowing 12 simultaneous analyses of HbA1c quantification in a whole blood sample. A sample dilution with hemolysing solution is prepared and injected by aspiration at the anodic end of the capillary. A high voltage protein separation is then performed and direct detection of the hemoglobins is made at the cathodic end of the capillary at 415 nm, which is the absorbance wave length specific to hemoglobins. Before each run, the capillaries are washed with a wash solution and prepared for the next analysis with buffer.

Direct detection provides accurate relative quantification of individual hemoglobin A1c fraction. In addition, the high resolution of CAPI 3 Hb A1c procedure allows the quantification of HbA1c even in the presence of labile HbA1c. carbamylated and acetylated hemoglobins, and major hemoqlobin variants.

By using an alkaline pH buffer, normal and abnormal (or variant) hemoglobins are detected in the following order, from cathode to anode: A2/C, E, S/D, F, A0, other Hb (including minor Hb A1) and then A1c.

The HbA1c concentrations are standardized and indicated in %HbA1c (DCCT/NGSP) and in mmol/mol (IFCC) units.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

A method comparison study of 152 variant-free whole blood samples covering the measuring range were evaluated using the Capi3 Hb A1c kit and the CAPILLARYS 3 TERA instrument. The results were compared to the testing performed at a NGSP reference laboratory using the cleared HPLC HbA1c method (Automated Glycohemoglobin Analyzer HLC-712G8).

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance Data:
a. Precision / Reproducibility:-
The precision of the CAPI 3 Hb A1c procedure using the CAPILLARYS 3 TERA was evaluated based on CLSI guidelines EP05-A3 guidelines, Evaluation of Quantitative Measurement Procedures. Four whole blood samples at the following targeted HbA1c concentration of ~ 5%, ~ 6.5%, ~ 8%, and ~12% were used in the study. The study included two quality control materials and two calibrators. The samples were analyzed in duplicate on two capillaries per run on 3 instruments. The studied used three lots of kits over 24 days yielding a total of 1728 results over total testing time of 72 days.

Key results: Total reproducibility for samples ranged from 0.83 to 2.21 SD (mmol/mol) and 0.07 to 0.20 SD (%).

b. Linearity / assay reportable range
A linearity study was performed per CLSI EP06-A: Evaluation of Quantitative Measuring Procedures: A Statistical Approach, Linearity across the reportable range was performed using low 3.8% Hb A1c (18 mmol/mol) and high 17.3% (166 mmol/mol).
Mixture of 2 different blood samples:
2 characteristic blood samples, including a normal sample and an elevated HbA10 level sample were mixed within different proportions and the mixtures were electrophoresed with the CAPI 3 Hb A1c procedure. For each mixture, samples were analyzed in triplicate.
The tests were determined to be linear within the entire range studied for HbA% hemoglobin fraction. The stated measuring range is 20 mmol/mol to 157 mmol/mol HbA+c (4.0 % to 16.5 % HbA1c).
Dilution of 4 different blood samples in hemolysing solution:
4 different characteristic blood samples, including 1 normal sample with HbA1c concentration at 21 mmol/mol (4.1 % HbA1c), 1 sample with HbA1c level close to the cut-off value with HbA1c concentration at 47 mmol/mol (6.4 % HbA1c) and 2 elevated HbA1c level samples with HbA1c concentrations at 82 mmol/mol (9.6 % HbA1c) and at 134 mmol/mol (14.4 % HbA1c), were all serially diluted in hemolysing solution and electrophoresed with the CAPI 3 Hb A1c procedure. The tests were determined to be linear within the entire ranges studied from 2.9 to 30.5 g/dL total hemoglobin and HbA1c fraction concentration and percentage were not affected by the hemoglobin concentration of the samples.

e. Comparison Studies
A method comparison study of 152 variant-free whole blood samples covering the measuring range were evaluated using the Capi3 Hb A1c kit and the CAPILLARYS 3 TERA instrument. The results were compared to the testing performed at a NGSP reference laboratory using the cleared HPLC HbA1c method (Automated Glycohemoglobin Analyzer HLC-712G8).
Correlation coefficient: 0.999
Slope: 1.014 (1.007 to 1.021)
y-intercept: -0.142 (-0.197 to -0.087)
Average bias (all samples): -0.04 (-0.06 to -0.02)
Bias at normal range: The bias at 6.5 is -0.05 (-0.07 to -0.03)

f. Total Error Calculations
Total error (TE) is calculated for 4 concentrations, corresponding to the concentrations of the samples used in the reproducibility study, (5.2 %, 6.5 %, 8.1 % and 11.9 %) using the results of bias estimation (%Bias) and coefficients of variation (CV).
Total Error is calculated as follows: %TE=|%Bias| + 1.96 CV (1 + %Bias/100)).
Results:
Target 5.2%: TE 4.4%
Target 6.5%: TE 2.9%
Target 8.1%: TE 2.3%
Target 11.9%: TE 3.6%

g. Interferences
No interference with the CAPI 3 Hb A1c procedure was detected due to the blood sample's high concentration of the following interfering factors tested at levels equal to the concentrations listed.
Hemoglobin Variant Study:
Hemoglobin S: 1.6% (0% - 3.2%) relative bias at ~6.5% Hb A1c; 2.9% (1.1% - 5.4%) relative bias at ~9% Hb A1c
Hemoglobin C: -1.8% (-3.1% - 0%) relative bias at ~6.5% Hb A1c; 3.9% (3.3% - 4.5%) relative bias at ~9% Hb A1c
Hemoglobin D: 1.0% (0% - 1.6%) relative bias at ~6.5% Hb A1c; 0.8% (0% - 2.4%) relative bias at ~9% Hb A1c
Hemoglobin E: 1.5% (-1.5% - 1.6%) relative bias at ~6.5% Hb A1c; 1.2% (0%-2.5%) relative bias at ~9% Hb A1c
Hemoglobin A2: 0.7% (0%-1.5%) relative bias at ~6.5% Hb A1c; 0.4% (0%-1.1%) relative bias at ~9% Hb A1c
Hemoglobin F: -4.1% (-3.3% -4.9 %) relative bias at ~6.5% Hb A1c; -0.8% (0%-2.0%) relative bias at ~9% Hb A1c

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K131580

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.1373 Hemoglobin A1c test system.

(a)
Identification. A hemoglobin A1c test system is a device used to measure the percentage concentration of hemoglobin A1c in blood. Measurement of hemoglobin A1c is used as an aid in the diagnosis of diabetes mellitus and as an aid in the identification of patients at risk for developing diabetes mellitus.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must have initial and annual standardization verification by a certifying glycohemoglobin standardization organization deemed acceptable by FDA.
(2) The premarket notification submission must include performance testing to evaluate precision, accuracy, linearity, and interference, including the following:
(i) Performance testing of device precision must, at a minimum, use blood samples with concentrations near 5.0 percent, 6.5 percent, 8.0 percent, and 12 percent hemoglobin A1c. This testing must evaluate precision over a minimum of 20 days using at least three lots of the device and three instruments, as applicable.
(ii) Performance testing of device accuracy must include a minimum of 120 blood samples that span the measuring interval of the device and compare results of the new device to results of a standardized test method. Results must demonstrate little or no bias versus the standardized method.
(iii) Total error of the new device must be evaluated using single measurements by the new device compared to results of the standardized test method, and this evaluation must demonstrate a total error less than or equal to 6 percent.
(iv) Performance testing must demonstrate that there is little to no interference from common hemoglobin variants, including Hemoglobin C, Hemoglobin D, Hemoglobin E, Hemoglobin A2, and Hemoglobin S.
(3) When assay interference from Hemoglobin F or interference with other hemoglobin variants with low frequency in the population is observed, a warning statement must be placed in a black box and must appear in all labeling material for these devices describing the interference and any affected populations.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 12, 2017

SEBIA, INC. KAREN ANDERSON DIRECTOR OF TECHNICAL AND QUALITY ASSURANCE 1705 CORPORATE DRIVE SUITE 400 NORCROSS GA 30093

Re: K171537

Trade/Device Name: CAPI 3 Hb A1c Regulation Number: 21 CFR 862.1373 Regulation Name: Hemoglobin A1c Test System Regulatory Class: II Product Code: PDJ Dated: July 24, 2017 Received: July 27, 2017

Dear Ms. Karen Anderson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K171537

Device Name CAPI 3 Hb A1c

Indications for Use (Describe)

The CAPI 3 Hb A1c kit is intended for separation and quantification of the HbA1c glycated fraction of hemoglobin (in IFCC unit (mmol/mol) and NGSP unit (%)) in venous whole human blood, by capillary electrophoresis in alkaline buffer with the CAPILLARYS 3 TERA instrument of hemoglobin A1c is used as an aid in diagnosis of diabetes, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus. The CAPI 3 Hb A1c kit is intended for in vitro Diagnostic Use Only.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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3

510K SUMMARY (Summary of Safety and Effectiveness) - K171537

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

Submitter Name	Sebia, Inc.
Address	1705 Corporate Drive Suite 400
Norcross, Georgia 30093, USA
Contact	Karen Anderson, Dir of Technical and QA
Phone: 1-800-835-6497
Fax: 770-446-8511
Email: karen.anderson@sebia-usa.com
Aigars Brants, Ph.D, Scientific Affairs Officer
Phone 1-800-835-6497
Fax 770-446-8511
Email: aigars.brants@sebia-usa.com
Date Prepared	August 14, 2017
Manufacturing	Sebia
Parc Technologique Léonard de Vinci
Rue Léonard de Vinci,
CP 8010 LISSES, 91008 EVRY Cedex
FRANCE
Phone: (33) 1 69 89 80 80
Fax: (33) 1 69 89 78 78
Product Name	CAPI 3 Hb A1c
Common Name	Whole blood hemoglobin A1c (HbA1c) by capillary
electrophoresis
Product Regulation No.	21 CFR 862.1373
Product Codes	PDJ
Device classification and Panel
Classification	Class II , Clinical Chemistry(75)
Establishment Registration No.	8023024

510(k) Summary 1

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1. DEVICE DESCRIPTION

The CAPILLARYS 3 TERA instrument uses the principle of capillary electrophoresis in free solution. With this technique, charged molecules are separated by their electrophoretic mobility in an alkaline buffer with a specific pH. Separation occurs according to the electrolyte pH and electroosmotic flow.

The CAPILLARYS 3 TERA instrument has silica capillaries functioning in parallel allowing 12 simultaneous analyses of HbA1c quantification in a whole blood sample. A sample dilution with hemolysing solution is prepared and injected by aspiration at the anodic end of the capillary. A high voltage protein separation is then performed and direct detection of the hemoglobins is made at the cathodic end of the capillary at 415 nm, which is the absorbance wave length specific to hemoglobins. Before each run, the capillaries are washed with a wash solution and prepared for the next analysis with buffer.

Direct detection provides accurate relative quantification of individual hemoglobin A1c fraction. In addition, the high resolution of CAPI 3 Hb A1c procedure allows the quantification of HbA1c even in the presence of labile HbA1c. carbamylated and acetylated hemoglobins, and major hemoqlobin variants.

By using an alkaline pH buffer, normal and abnormal (or variant) hemoglobins are detected in the following order, from cathode to anode: A2/C, E, S/D, F, A0, other Hb (including minor Hb A1) and then A1c.

The HbA1c concentrations are standardized and indicated in %HbA1c (DCCT/NGSP) and in mmol/mol (IFCC) units.

Reagents:

CAPI 3 Hb A1c KIT

ITEMS	PN 2515
Buffer (ready to use)	2 vials, 700 mL each
Hemolysing solution (ready to use)	1 vial, 700 mL
Filters	4 filters

Additional reagents not included in the CAPI 3 Hb A1c KIT

ITEMS	PN	COMPONENTS
CAPICLEAN CAPILLARYS 3	2060	1 vial, 25 mL
CAPILLARYS 3 WASH SOLUTION	2062	1 vial, 75mL

5

| CAPI 3 DISPOSABLES KIT | 2580 | 10 packs of 14 reagent cups
5 bins for used reagent cups |
|--------------------------------------|------|-------------------------------------------------------------|
| TEST TUBES | 9214 | 200 of 100 mm-tubes |
| CAPI 3 BINS FOR USED REAGENT
CUPS | 2581 | 5 units |
| TUBES AND CAPS FOR | 9202 | 20 units |
| CONTROLS | 9205 | 500 units |
| CAPI 3 REAGENT CUPS | 2582 | 24 packs of 14 reagent cups |

2. INDICATIONS FOR USE

CAPI 3 Hb A1c kit:

The CAPI 3 Hb A1c kit is intended for separation and quantification of the HbA1c glycated fraction of hemoglobin (in IFCC unit (mmol/mol) and NGSP unit (%)) in venous whole human blood, by capillary electrophoresis in alkaline buffer with the CAPILLARYS 3 TERA instrument. Measurement of hemoglobin A1c is used as an aid in diagnosis of diabetes, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of longterm blood glucose control in individuals with diabetes mellitus. The CAPI 3 Hb A1c kit is intended for in vitro Diagnostic Use Only.

3. TECHNOLOGICAL CHARACTERISTICS

The CAPILLARYS 3 TERA instrument uses the principle of capillary electrophoresis in free solution which is the most common form of capillary electrophoresis. With this technique, charged molecules are separated by their electrophoretic mobility in an alkaline buffer with a specific pH. Separation also occurs according to the electrolyte pH and electroosmotic flow.

The CAPILLARYS 3 TERA instrument has silica capillaries functioning in parallel allowing 12 simultaneous analyses of Hb A1c quantification in a whole blood sample. A sample dilution with hemolysing solution is prepared and injected by aspiration at the anodic end of the capillary. A high voltage protein separation is then performed and direct detection of the hemoglobins is made at the cathodic end of the capillary at 415 nm, which is the absorbance wave length specific to hemoglobins. Before each run, the capillaries are washed with a wash solution and prepared for the next analysis with buffer.

Direct detection provides accurate relative quantification of individual hemoglobin A1cfraction. In addition, the high resolution of CAPI 3 Hb A1c procedure allows the quantification of HbA1c, and particularly, even in the presence of labile HbA1c, carbamylated and acetylated hemoglobins, and major hemoglobin variants.

By using an alkaline pH buffer, normal and abnormal (or variant) hemoglobins are detected in the following order, from cathode to anode: A2/C, E, S/D, F, A0, other Hb (including minor Hb A1) and then A1c.

6

4. SUBSTANTIAL EQUIVALENCE INFORMATION:

| Predicate Device Name | Predicate Device
510(k) number | Product Code | Regulation No |
|------------------------------------------------------------|-----------------------------------|--------------|---------------|
| Tosoh Automated
Glycohemoglobin Analyzer HLC-
723G-8 | K131580 | PDJ | 862.1373 |

Similarities between the candidate device (CAPI 3 Hb A1c) and the predicate device (Tosoh HLC-723G8, K131580 (Table A).

	Similarities
Table A	Sebia CAPI 3 Hb A1c Candidate
Device	Tosoh HLC-723G8 Predicate
Device (K131580)
Intended use	The CAPI 3 Hb A1c kit is intended for
separation and quantification of the HbA1c
glycated fraction of hemoglobin (in IFCC unit
(mmol/mol) and NGSP unit (%)) in venous
whole human blood, by capillary
electrophoresis in alkaline buffer with the
CAPILLARYS 3 TERA instrument.
Measurement of hemoglobin A1c is used as
an aid in diagnosis of diabetes, as an aid to
identify patients who may be at risk for
developing diabetes mellitus, and for the
monitoring of long-term blood glucose control
in individuals with diabetes mellitus. The CAPI
3 Hb A1c kit is intended for in vitro Diagnostic
Use Only.	The Tosoh Automated
Glycohemoglobin Analyzer
HLC723G8 is intended for the in vitro
diagnostic use for the measurement of
% hemoglobin A1c (HbA1c)
(DCCT/NGSP) and mmol/mol
hemoglobin A1c (IFCC) in whole
blood specimens. This test is to be
used as an aid in diagnosis of
diabetes and identifying patients who
may be at risk of developing diabetes.
Specimen Type	Human Whole Blood	Human Whole Blood
Standardization	Traceable to the Diabetes Control and
Complications Trial (DCCT) reference
method and IFCC. Certified via the National
Glycohemoglobin Standardization Program (
NGSP)	Same
Linearity
Measuring Range	4.0 - 16.5% (NGSP)
20 - 157 mmol/mol (IFCC)	4.0 - 16.9 %

7

	Concentration	TE%	Concentration	TE%
Total Error
allowable bias 6%	5.2	4.4	5.0	5.8
	6.5	2.9	6.5	2.8
	8.1	2.3	8.0	3.0
	11.9	3.6	12.0	3.1
Hemoglobin
Variant
Interferences	HbA2, HbF, HbS, HbC, HbD,
does not interfere with this assay			HbA2, HbF, HbS, HbC, HbD, does
not interfere with this assay

Table B. Differences between the predicate device (CAPI 3 Hb A1c) and the candidate device (Tosoh HLC-723G8, K131580) in (Table B).

	Differences
Table B	Sebia CAPI 3 Hb A1c
Candidate Device	Tosoh HLC-723G8
Predicate Device (K131580)
Assay Principle	Capillary electrophoresis	Ion-exchange HPLC
Hemoglobin
Variant
Interferences	Hb E no interference	Hb E has known interference, a HbE
flag is displayed and no Hb A1c is
reported.

8

5. Performance Data:

a. Precision / Reproducibility:-

The precision of the CAPI 3 Hb A1c procedure using the CAPILLARYS 3 TERA was evaluated based on CLSI guidelines EP05-A3 guidelines, Evaluation of Quantitative Measurement Procedures. Four whole blood samples at the following targeted HbA1c concentration of ~ 5%, ~ 6.5%, ~ 8%, and ~12% were used in the study. The study included two quality control materials and two calibrators. The samples were analyzed in duplicate on two capillaries per run on 3 instruments. The studied used three lots of kits over 24 days yielding a total of 1728 results over total testing time of 72 days.

| Sample | Mean
(mmol/mol) | Within-
capillary | | Betweencapillary | | Between-run | | Between-day | | Between-lot | | Betweeninstrument | | Total
reproducibility
(*) | |
|-----------------|--------------------|----------------------|------|------------------|------|-------------|------|-------------|------|-------------|------|-------------------|------|---------------------------------|------|
| | | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV |
| Sample No.
1 | 33 | 0,50 | 1,5% | 0,48 | 1,4% | 0,00 | 0,0% | 0,24 | 0,7% | 0,40 | 1,2% | 0,18 | 0,6% | 0,86 | 2,6% |
| Sample No.
2 | 34 | 0,49 | 1,4% | 0,52 | 1,5% | 0,00 | 0,0% | 0,28 | 0,8% | 0,49 | 1,5% | 0,00 | 0,0% | 0,91 | 2,7% |
| Sample No.
3 | 37 | 0,44 | 1,2% | 0,51 | 1,4% | 0,00 | 0,0% | 0,27 | 0,7% | 0,42 | 1,1% | 0,00 | 0,0% | 0,84 | 2,3% |
| Sample No.
4 | 48 | 0,56 | 1,2% | 0,43 | 0,9% | 0,26 | 0,5% | 0,22 | 0,5% | 0,38 | 0,8% | 0,00 | 0,0% | 0,83 | 1,7% |
| Sample No.
5 | 61 | 0,53 | 0,9% | 0,43 | 0,7% | 0,00 | 0,0% | 0,43 | 0,7% | 0,09 | 0,1% | 1,52 | 2,6% | 1,72 | 2,9% |
| Sample No.
6 | 65 | 0,62 | 1,0% | 0,43 | 0,7% | 0,00 | 0,0% | 0,31 | 0,5% | 0,23 | 0,4% | 0,13 | 0,2% | 0,86 | 1,3% |
| Sample No.
7 | 86 | 0,64 | 0,7% | 0,49 | 0,6% | 0,00 | 0,0% | 0,39 | 0,5% | 0,72 | 0,8% | 0,00 | 0,0% | 1,14 | 1,3% |
| Sample No.
8 | 107 | 0,74 | 0,7% | 0,83 | 0,8% | 0,00 | 0,0% | 0,67 | 0,6% | 1,79 | 1,7% | 0,00 | 0,0% | 2,21 | 2,1% |

(*) Total reproducibility includes : within-capillary, between-run, between-day, between-lot and between-instrument.

| Sample | Mean | Within-
capillary | | Betweencapillary | | Between-run | | Between-day | | Between-lot | | Betweeninstrument | | Total
reproducibility
(*) | |
|-----------------|------|----------------------|------|------------------|------|-------------|------|-------------|------|-------------|------|-------------------|------|---------------------------------|------|
| | (%) | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV |
| Sample No.
1 | 5,2 | 0,05 | 0,9% | 0,04 | 0,8% | 0,00 | 0,0% | 0,02 | 0,4% | 0,04 | 0,7% | 0,02 | 0,3% | 0,08 | 1,5% |
| Sample No.
2 | 5,2 | 0,05 | 0,9% | 0,05 | 0,9% | 0,00 | 0,0% | 0,03 | 0,6% | 0,04 | 0,7% | 0,00 | 0,0% | 0,08 | 1,6% |
| Sample No.
3 | 5,5 | 0,04 | 0,8% | 0,04 | 0,8% | 0,00 | 0,0% | 0,03 | 0,5% | 0,04 | 0,7% | 0,00 | 0,0% | 0,08 | 1,4% |
| Sample No.
4 | 6,5 | 0,05 | 0,7% | 0,04 | 0,5% | 0,02 | 0,3% | 0,02 | 0,3% | 0,03 | 0,5% | 0,00 | 0,0% | 0,07 | 1,1% |
| Sample No.
5 | 7,7 | 0,05 | 0,7% | 0,04 | 0,5% | 0,00 | 0,0% | 0,04 | 0,5% | 0,01 | 0,2% | 0,13 | 1,7% | 0,15 | 2,0% |
| Sample No.
6 | 8,1 | 0,06 | 0,7% | 0,04 | 0,5% | 0,00 | 0,0% | 0,03 | 0,4% | 0,02 | 0,3% | 0,01 | 0,1% | 0,08 | 1,0% |
| Sample No.
7 | 10,1 | 0,06 | 0,6% | 0,05 | 0,5% | 0,00 | 0,0% | 0,04 | 0,4% | 0,07 | 0,7% | 0,00 | 0,0% | 0,11 | 1,1% |
| Sample No.
8 | 11,9 | 0,07 | 0,6% | 0,08 | 0,6% | 0,00 | 0,0% | 0,06 | 0,5% | 0,16 | 1,4% | 0,00 | 0,0% | 0,20 | 1,7% |

(*) Total reproducibility includes : within-capillary, between-cay, between-day, between-ot and between-instrument.

9

The reproducibility within the same instrument is summarized in the following tables:

including within-capillary, between-capillary, between-run, between-day, between-lot and total reproducibility precision estimates (SD and %CV) for the HbA1c concentrations (in mmol/mol) and percentages for each instrument.
including the within-lot precision estimates (SD and %CV) for the HbA10 concentrations -(in mmol/mol) and percentages for each lot on each instrument.

| Sample | Mean
(mmol/mol) | Within-capillary | | Betweencapillary | | Between-run | | Between-day | | Between-lot | | Total
reproducibility
(*) | |
|--------------|--------------------|------------------|------|------------------|------|-------------|------|-------------|------|-------------|------|---------------------------------|------|
| | | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV |
| Sample No. 1 | 33 | 0,50 | 1,5% | 0,42 | 1,3% | 0,00 | 0,0% | 0,19 | 0,6% | 0,42 | 1,3% | 0,80 | 2,4% |
| Sample No. 2 | 34 | 0,42 | 1,3% | 0,49 | 1,4% | 0,00 | 0,0% | 0,28 | 0,8% | 0,62 | 1,8% | 0,94 | 2,8% |
| Sample No. 3 | 37 | 0,47 | 1,3% | 0,44 | 1,2% | 0,00 | 0,0% | 0,30 | 0,8% | 0,45 | 1,2% | 0,84 | 2,3% |
| Sample No. 4 | 48 | 0,55 | 1,1% | 0,38 | 0,8% | 0,18 | 0,4% | 0,28 | 0,6% | 0,49 | 1,0% | 0,89 | 1,9% |
| Sample No. 5 | 61 | 0,51 | 0,9% | 0,50 | 0,8% | 0,00 | 0,0% | 0,37 | 0,6% | 0,07 | 0,1% | 0,81 | 1,4% |
| Sample No. 6 | 65 | 0,59 | 0,9% | 0,38 | 0,6% | 0,00 | 0,0% | 0,34 | 0,5% | 0,38 | 0,6% | 0,86 | 1,3% |
| Sample No. 7 | 86 | 0,73 | 0,8% | 0,47 | 0,5% | 0,00 | 0,0% | 0,44 | 0,5% | 1,00 | 1,2% | 1,39 | 1,6% |
| Sample No. 8 | 107 | 0,70 | 0,6% | 0,76 | 0,7% | 0,00 | 0,0% | 0,70 | 0,6% | 2,41 | 2,2% | 2,71 | 2,5% |

Instrument No. 1

(*) Total reproducibility includes : within-capillary, between-run, between-run, between-day and between-lot.

Sample	Mean (mmol/mol)	Within-lot (*)
		Lot No. 1		Lot No. 2		Lot No. 3
		SD	CV	SD	CV	SD	CV
Sample No. 1	33	0,67	2,0%	0,62	1,9%	0,75	2,3%
Sample No. 2	34	0,72	2,1%	0,75	2,3%	0,65	1,9%
Sample No. 3	37	0,65	1,8%	0,70	1,9%	0,77	2,1%
Sample No. 4	48	0,80	1,7%	0,78	1,6%	0,70	1,5%
Sample No. 5	61	0,97	1,6%	0,60	1,0%	0,83	1,4%
Sample No. 6	65	0,76	1,2%	0,64	1,0%	0,93	1,4%
Sample No. 7	86	0,98	1,2%	0,72	0,8%	1,16	1,3%
Sample No. 8	107	1,33	1,3%	1,20	1,1%	1,25	1,2%

(*) Within-lot reproducibility includes : within-capillary, between-run and between-day.

| Sample | Mean
(%) | Within-capillary | | Betweencapillary | | Between-run | | Between-day | | Between-lot | | Total
reproducibility
(*) | |
|--------------|-------------|------------------|------|------------------|------|-------------|------|-------------|------|-------------|------|---------------------------------|------|
| | | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV |
| Sample No. 1 | 5,2 | 0,04 | 0,9% | 0,04 | 0,8% | 0,00 | 0,0% | 0,02 | 0,4% | 0,04 | 0,8% | 0,08 | 1,5% |
| Sample No. 2 | 5,2 | 0,04 | 0,8% | 0,05 | 0,9% | 0,00 | 0,0% | 0,03 | 0,6% | 0,05 | 0,9% | 0,08 | 1,6% |
| Sample No. 3 | 5,5 | 0,05 | 0,8% | 0,05 | 0,9% | 0,00 | 0,0% | 0,04 | 0,7% | 0,04 | 0,7% | 0,09 | 1,6% |
| Sample No. 4 | 6,5 | 0,05 | 0,7% | 0,04 | 0,6% | 0,02 | 0,3% | 0,02 | 0,2% | 0,05 | 0,7% | 0,08 | 1,2% |
| Sample No. 5 | 7,7 | 0,05 | 0,6% | 0,04 | 0.6% | 0,00 | 0,0% | 0,03 | 0,4% | 0,01 | 0.1% | 0,07 | 0,9% |
| Sample No. 6 | 8,1 | 0,06 | 0,7% | 0,04 | 0,5% | 0,00 | 0,0% | 0,03 | 0,4% | 0,03 | 0,4% | 0,08 | 1,0% |
| Sample No. 7 | 10,1 | 0,06 | 0,6% | 0,04 | 0,4% | 0,00 | 0,0% | 0,04 | 0,4% | 0,10 | 1,0% | 0,13 | 1,3% |
| Sample No. 8 | 11,9 | 0,07 | 0,6% | 0,07 | 0,6% | 0,00 | 0,0% | 0,06 | 0,5% | 0,21 | 1,8% | 0,24 | 2,0% |

510(k) Summary 7

10

(*) Total reproducibility includes : within-capillary, between-run, between-run, between-day and between-lot.

Sample	Mean (%)	Within-lot (*)
		Lot No. 1		Lot No. 2		Lot No. 3
		SD	CV	SD	CV	SD	CV
Sample No. 1	5,2	0,06	1,1%	0,07	1,3%	0,07	1,4%
Sample No. 2	5,2	0,06	1,2%	0,08	1,6%	0,06	1,2%
Sample No. 3	5,5	0,07	1,3%	0,07	1,4%	0,08	1,4%
Sample No. 4	6,5	0,07	1,1%	0,06	0,9%	0,07	1,0%
Sample No. 5	7,7	0,09	1,1%	0,06	0,8%	0,07	0,9%
Sample No. 6	8,1	0,08	0,9%	0,06	0,7%	0,09	1,1%
Sample No. 7	10,1	0,09	0,9%	0,08	0,8%	0,09	0,9%
Sample No. 8	11,9	0,12	1,0%	0,11	0,9%	0,12	1,0%

(*) Within-lot reproducibility includes : within-capillary, between-run and between-day.

Instrument No. 2

| Sample | Mean
(mmol/mol) | Within-
capillary | | Betweencapillary | | Between-run | | Between-day | | Between-lot | | Total
reproducibility
(*) | |
|--------------|--------------------|----------------------|------|------------------|------|-------------|------|-------------|------|-------------|------|---------------------------------|------|
| | | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV |
| Sample No. 1 | 33 | 0,57 | 1,7% | 0,55 | 1,7% | 0,00 | 0,0% | 0,22 | 0,7% | 0,45 | 1,4% | 0,94 | 2,8% |
| Sample No. 2 | 34 | 0,54 | 1,6% | 0,56 | 1,7% | 0,00 | 0,0% | 0,24 | 0,7% | 0,42 | 1,3% | 0,91 | 2,7% |
| Sample No. 3 | 37 | 0,45 | 1,2% | 0,53 | 1,5% | 0,00 | 0,0% | 0,23 | 0,6% | 0,31 | 0,8% | 0,80 | 2,2% |
| Sample No. 4 | 48 | 0,61 | 1,3% | 0,41 | 0,9% | 0,37 | 0,8% | 0,15 | 0,3% | 0,30 | 0,6% | 0,89 | 1,9% |
| Sample No. 5 | 61 | 0,55 | 0,9% | 0,28 | 0,5% | 0,00 | 0,0% | 0,48 | 0,8% | 0,00 | 0,0% | 0,78 | 1,3% |
| Sample No. 6 | 65 | 0,69 | 1,1% | 0,34 | 0,5% | 0,00 | 0,0% | 0,31 | 0,5% | 0,03 | 0,0% | 0,83 | 1,3% |
| Sample No. 7 | 86 | 0,58 | 0,7% | 0,55 | 0,6% | 0,00 | 0,0% | 0,40 | 0,5% | 0,41 | 0,5% | 0,99 | 1,1% |
| Sample No. 8 | 107 | 0,81 | 0,8% | 1,01 | 0,9% | 0,00 | 0,0% | 0,76 | 0,7% | 1,38 | 1,3% | 2,04 | 1,9% |

(*) Total reproducibility includes : within-capillary, between-run, between-day and between-lot.

| Sample | Mean
(mmol/mol) | Within-lot (*) | | | | | |
|--------------|--------------------|----------------|------|-----------|------|-----------|------|
| | | Lot No. 1 | | Lot No. 2 | | Lot No. 3 | |
| | | SD | CV | SD | CV | SD | CV |
| Sample No. 1 | 33 | 0,88 | 2,6% | 0,73 | 2,2% | 0,84 | 2,5% |
| Sample No. 2 | 34 | 0,88 | 2,6% | 0,65 | 2,0% | 0,90 | 2,7% |
| Sample No. 3 | 37 | 0,87 | 2,4% | 0,56 | 1,5% | 0,74 | 2,0% |
| Sample No. 4 | 48 | 0,79 | 1,7% | 0,89 | 1,9% | 0,86 | 1,8% |
| Sample No. 5 | 61 | 0,66 | 1,1% | 0,67 | 1,1% | 0,98 | 1,6% |
| Sample No. 6 | 65 | 0,75 | 1,2% | 0,77 | 1,2% | 0,99 | 1,5% |
| Sample No. 7 | 86 | 1,03 | 1,2% | 0,79 | 0,9% | 0,86 | 1,0% |
| Sample No. 8 | 107 | 1,73 | 1,6% | 1,45 | 1,4% | 1,47 | 1,4% |

(*) Within-lot reproducibility includes : within-capillary, between-run and between-day.

11

| Sample | Mean
(%) | Within-capillary | | Betweencapillary | | Between-run | | Between-day | | Between-lot | | Total
reproducibility
(*) | |
|--------------|-------------|------------------|------|------------------|------|-------------|------|-------------|------|-------------|------|---------------------------------|------|
| | | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV |
| Sample No. 1 | 5,2 | 0,05 | 1,0% | 0,05 | 0,9% | 0,00 | 0,0% | 0,02 | 0,4% | 0,05 | 0,9% | 0,09 | 1,7% |
| Sample No. 2 | 5,2 | 0,05 | 0,9% | 0,06 | 1,1% | 0,00 | 0,0% | 0,02 | 0,4% | 0,03 | 0,7% | 0,09 | 1,6% |
| Sample No. 3 | 5,5 | 0,04 | 0,8% | 0,04 | 0,8% | 0,00 | 0,0% | 0,02 | 0,4% | 0,04 | 0,8% | 0,08 | 1,4% |
| Sample No. 4 | 6,5 | 0,05 | 0,7% | 0,03 | 0,5% | 0,02 | 0,3% | 0,02 | 0,4% | 0,02 | 0,4% | 0,07 | 1,1% |
| Sample No. 5 | 7,7 | 0,05 | 0,7% | 0,03 | 0,3% | 0,00 | 0,0% | 0,05 | 0,6% | 0,01 | 0,1% | 0,08 | 1,0% |
| Sample No. 6 | 8,1 | 0,07 | 0,8% | 0,03 | 0,3% | 0,01 | 0,1% | 0,03 | 0,3% | 0,01 | 0,1% | 0,08 | 0,9% |
| Sample No. 7 | 10,1 | 0,05 | 0,5% | 0,05 | 0,5% | 0,00 | 0,0% | 0,03 | 0,3% | 0,05 | 0,5% | 0,10 | 1,0% |
| Sample No. 8 | 11,9 | 0,08 | 0,6% | 0,09 | 0,8% | 0,02 | 0,2% | 0,07 | 0,6% | 0,13 | 1,1% | 0,19 | 1,6% |

(*) Total reproducibility includes : within-capillary, between-run, between-day and between-lot.

Sample	Mean (%)	Within-lot (*)
		Lot No. 1		Lot No. 2		Lot No. 3
		SD	CV	SD	CV	SD	CV
Sample No. 1	5,2	0,08	1,5%	0,06	1,2%	0,08	1,6%
Sample No. 2	5,2	0,09	1,7%	0,07	1,3%	0,08	1,6%
Sample No. 3	5,5	0,06	1,2%	0,06	1,1%	0,07	1,3%
Sample No. 4	6,5	0,06	1,0%	0,06	1,0%	0,07	1,1%
Sample No. 5	7,7	0,06	0,8%	0,06	0,8%	0,10	1,2%
Sample No. 6	8,1	0,07	0,8%	0,08	0,9%	0,09	1,1%
Sample No. 7	10,1	0,10	1,0%	0,07	0,7%	0,08	0,8%
Sample No. 8	11,9	0,15	1,3%	0,14	1,2%	0,14	1,2%

(*) Within-lot reproducibility includes : within-capillary, between-run and between-run and between-day.

Instrument No. 3

| Sample | Mean
(mmol/mol) | Within-capillary | | Betweencapillary | | Between-run | | Between-day | | Between-lot | | Total
reproducibility
(*) | |
|--------------|--------------------|------------------|------|------------------|------|-------------|------|-------------|------|-------------|------|---------------------------------|------|
| | | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV |
| Sample No. 1 | 33 | 0,44 | 1,3% | 0,46 | 1,4% | 0,00 | 0,0% | 0,30 | 0,9% | 0,33 | 1,0% | 0,77 | 2,3% |
| Sample No. 2 | 34 | 0,49 | 1,4% | 0,50 | 1,5% | 0,00 | 0,0% | 0,32 | 0,9% | 0,40 | 1.2% | 0,87 | 2,6% |
| Sample No. 3 | 37 | 0,40 | 1,1% | 0,54 | 1,5% | 0,00 | 0,0% | 0,29 | 0,8% | 0,48 | 1,3% | 0,88 | 2,4% |
| Sample No. 4 | 48 | 0,52 | 1,1% | 0,49 | 1,0% | 0,17 | 0,4% | 0,21 | 0,4% | 0,32 | 0,7% | 0,83 | 1,7% |
| Sample No. 5 | 61 | 0,54 | 0,9% | 0,46 | 0,7% | 0,00 | 0,0% | 0,42 | 0,7% | 0,15 | 0,2% | 0,84 | 1,3% |
| Sample No. 6 | 65 | 0,59 | 0,9% | 0,55 | 0,8% | 0,00 | 0,0% | 0,28 | 0,4% | 0,12 | 0,2% | 0,86 | 1,3% |
| Sample No. 7 | 86 | 0,58 | 0,7% | 0,45 | 0,5% | 0,00 | 0,0% | 0,31 | 0,4% | 0,61 | 0,7% | 1,01 | 1,2% |
| Sample No. 8 | 107 | 0.69 | 0,6% | 0,68 | 0,6% | 0,00 | 0,0% | 0,53 | 0,5% | 1,39 | 1,3% | 1,77 | 1,7% |

(*) Total reproducibility includes : within-capillary, between-run, between-day and between-lot.

12

Sample	Mean (mmol/mol)	Within-lot (*)
		Lot No. 1		Lot No. 2		Lot No. 3
		SD	CV	SD	CV	SD	CV
Sample No. 1	33	0,61	1,8%	0,89	2,7%	0,57	1,7%
Sample No. 2	34	0,64	1,9%	1,00	3,0%	0,59	1,7%
Sample No. 3	37	0,53	1,4%	0,94	2,6%	0,67	1,8%
Sample No. 4	48	0,72	1,5%	0,88	1,8%	0,74	1,5%
Sample No. 5	61	0,78	1,2%	0,87	1,4%	0,83	1,3%
Sample No. 6	65	0,71	1,1%	0,88	1,4%	0,96	1,5%
Sample No. 7	86	0,69	0,8%	0,76	0,9%	0,93	1,1%
Sample No. 8	107	1,09	1,0%	1,16	1,1%	1,09	1,0%

(*) Within-lot reproducibility includes : within-capillary, between-run and between-day.

| Sample | Mean
(%) | Within-capillary | | Betweencapillary | | Between-run | | Between-day | | Between-lot | | Total
reproducibility
(*) | |
|--------------|-------------|------------------|------|------------------|------|-------------|------|-------------|------|-------------|------|---------------------------------|------|
| | | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV |
| Sample No. 1 | 5,2 | 0,05 | 0,9% | 0,04 | 0,8% | 0,00 | 0,0% | 0,03 | 0,5% | 0,01 | 0,2% | 0,07 | 1,3% |
| Sample No. 2 | 5,2 | 0,05 | 0,9% | 0,04 | 0,8% | 0,00 | 0,0% | 0,03 | 0,6% | 0,03 | 0,6% | 0,08 | 1,5% |
| Sample No. 3 | 5,5 | 0,04 | 0,8% | 0,04 | 0,7% | 0,00 | 0,0% | 0,02 | 0,4% | 0,04 | 0,7% | 0,07 | 1,3% |
| Sample No. 4 | 6,5 | 0,05 | 0,8% | 0,04 | 0,6% | 0,02 | 0,4% | 0,02 | 0,2% | 0,03 | 0,4% | 0,07 | 1,1% |
| Sample No. 5 | 7,7 | 0,05 | 0,6% | 0,04 | 0,6% | 0,00 | 0,0% | 0,03 | 0,4% | 0,02 | 0,3% | 0,08 | 1,0% |
| Sample No. 6 | 8,1 | 0,06 | 0,7% | 0,05 | 0,6% | 0,00 | 0,0% | 0,03 | 0,4% | 0,01 | 0,1% | 0,08 | 1,0% |
| Sample No. 7 | 10,1 | 0,05 | 0,5% | 0,04 | 0,4% | 0,00 | 0,0% | 0,03 | 0,3% | 0,06 | 0,6% | 0,10 | 1,0% |
| Sample No. 8 | 11,9 | 0,06 | 0,5% | 0,07 | 0,6% | 0,00 | 0,0% | 0,05 | 0,4% | 0,13 | 1,1% | 0,17 | 1,4% |

(*) Total reproducibility includes : within-capillary, between-run, between-run, between-lot.

| Sample | Mean
(%) | Within-lot (*) | | | | | |
|--------------|-------------|----------------|------|-----------|------|-----------|------|
| | | Lot No. 1 | | Lot No. 2 | | Lot No. 3 | |
| | | SD | CV | SD | CV | SD | CV |
| Sample No. 1 | 5,2 | 0,05 | 1,0% | 0,09 | 1,6% | 0,06 | 1,2% |
| Sample No. 2 | 5,2 | 0,06 | 1,2% | 0,09 | 1,7% | 0,06 | 1,2% |
| Sample No. 3 | 5,5 | 0,05 | 0,9% | 0,08 | 1,4% | 0,06 | 1,1% |
| Sample No. 4 | 6,5 | 0,07 | 1,0% | 0,08 | 1,2% | 0,06 | 1,0% |
| Sample No. 5 | 7,7 | 0,07 | 0,9% | 0,08 | 1,0% | 0,07 | 0,9% |
| Sample No. 6 | 8,1 | 0,07 | 0,9% | 0,08 | 1,0% | 0,09 | 1,2% |
| Sample No. 7 | 10,1 | 0,06 | 0,6% | 0,07 | 0,7% | 0,10 | 0,9% |
| Sample No. 8 | 11,9 | 0,11 | 0,9% | 0,11 | 0,9% | 0,10 | 0,9% |

(*) Within-lot reproducibility includes : within-capillary, between-run and between-day.

13

b. Linearity / assay reportable range

A linearity study was performed per CLSI EP06-A: Evaluation of Quantitative Measuring Procedures: A Statistical Approach, Linearity across the reportable range was performed using low 3.8% Hb A1c (18 mmol/mol) and high 17.3% (166 mmol/mol).

Mixture of 2 different blood samples:

2 characteristic blood samples, including a normal sample and an elevated HbA10 level sample were mixed within different proportions and the mixtures were electrophoresed with the CAPI 3 Hb A1c procedure. For each mixture, samples were analyzed in triplicate.

The tests were determined to be linear within the entire range studied for HbA% hemoglobin fraction. The stated measuring range is 20 mmol/mol to 157 mmol/mol HbA+c (4.0 % to 16.5 % HbA1c).

Dilution of 4 different blood samples in hemolysing solution :

4 different characteristic blood samples, including 1 normal sample with HbA1c concentration at 21 mmol/mol (4.1 % HbA1c), 1 sample with HbA1c level close to the cut-off value with HbA1c concentration at 47 mmol/mol (6.4 % HbA1c) and 2 elevated HbA1c level samples with HbA1c concentrations at 82 mmol/mol (9.6 % HbA1c) and at 134 mmol/mol (14.4 % HbA1c), were all serially diluted in hemolysing solution and electrophoresed with the CAPI 3 Hb A1c procedure. The tests were determined to be linear within the entire ranges studied from 2.9 to 30.5 g/dL total hemoglobin and HbA1c fraction concentration and percentage were not affected by the hemoglobin concentration of the samples.

c. Traceability, Stability (controls, calibrators, or methods)

The CAPI 3 Hb A1c test standardization is traceable to the International Federation of Clinical Chemistry (IFCC) reference calibrators.

The CAPI 3 Hb A1c assay is NGSP certified. The NGSP certification expires in one year. See the NGSP website for current certification at http://www.ngsp.org

Hb A1c results are provided in two different units: NGSP equivalent units (%) and IFCC equivalent units (mmol/mol).

d. Calibrators and Controls

The Hb A1c CAPILLARY CALIBRATORS are required for use with this device. Value assignment and stability protocal and acceptance criteria were previously reviewed and cleared in K162281 and K122101.

Sebia MULTI-SYSTEM Hb A1c CAPILLARYS CONTROLS are required for use with this device and cleared in submission K162281.

14

e. Comparison Studies

A method comparison study of 152 variant-free whole blood samples covering the measuring range were evaluated using the Capi3 Hb A1c kit and the CAPILLARYS 3 TERA instrument. The results were compared to the testing performed at a NGSP reference laboratory using the cleared HPLC HbA1c method (Automated Glycohemoglobin Analyzer HLC-712G8).

To support the diagnostic claim for HbA1c the samples spanned around the decision points as follows:

HbA1c level	Number of samples	% of samples
HbA1c ≤ 5 %	9	6
5,0 % 9,0 %	17	11
Total	152	100

HbA1c results given as a NGSP unit (%)

| Fraction | Correlation coefficient | y-intercept | Slope | Range of HbA1c % values
CAPI 3 Hb A1c |
|----------|-------------------------|-------------|-------|------------------------------------------|
| HbA1c | 0,999 | -0,142 | 1,014 | 3,9 - 16,5 |

152 samples

Regression Analysis (HbA1c fraction)
Ordinary line ar fit
95 % Confidence Intervals are shown in parentheses
Points (Plotted/Total)	152/152
Results Ranges	3,9 to 16,5
Normal range	23%. HbA1c results are invalid for patients with high amounts of HbF (>23%) including those with known Hereditary Persistence of Fetal Hemoglobin

Levels of Hb A2 up to 7.8 % in the blood sample do not interfere with HbA1c fraction quantification.
No interference has been observed with HbA1c fraction quantification due to the presence of major abnormal hemoglobins Hb S (≤ 40.8 %), Hb C (≤ 37.6 %), Hb D (≤ 41.3 %) and Hb E (≤ 26.8 %).

h. Expected Values/ Reference Range

Hemoglobin Are expected value range was cited from the American Diabetes Association (Standards of Medical Care in Diabetes 2016, 39 (Suppl 1)). The American Diabetes Association's (ADA) most recent Clinical Practice are:

Category	HbA1c Range (IFCC)	HbA1c Range (NGSP/DCCT)
Normal